[Federal Register Volume 84, Number 77 (Monday, April 22, 2019)]
[Rules and Regulations]
[Pages 16616-16617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08031]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 414

[CMS-6080-N2]


Medicare Program; Update to the Required Prior Authorization List 
of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies 
(DMEPOS) Items That Require Prior Authorization as a Condition of 
Payment

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Update to list.

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SUMMARY: This document announces the addition of 12 Healthcare Common 
Procedure Coding System (HCPCS) codes to the Required Prior 
Authorization List of Durable Medical Equipment, Prosthetics, 
Orthotics, and Supplies (DMEPOS) Items that require prior authorization 
as a condition of payment.

DATES: Phase one of implementation is effective on July 22, 2019. Phase 
two of implementation is effective on October 21, 2019.

FOR FURTHER INFORMATION CONTACT:
    Virginia Boulin, (410) 786-1079.
    Erica Ross, (410) 786-7480.

SUPPLEMENTARY INFORMATION: 

I. Background

    Sections 1832, 1834, and 1861 of the Social Security Act (the Act) 
establish that the provision of durable medical equipment, prosthetics, 
orthotics, and supplies (DMEPOS) are covered benefits under Part B of 
the Medicare program.
    Section 1834(a)(15) of the Act authorizes the Secretary to develop 
and periodically update a list of DMEPOS items that the Secretary 
determines, on the basis of prior payment experience, are frequently 
subject to unnecessary utilization and to develop a prior authorization 
process for these items.
    In the December 30, 2015 final rule (80 FR 81674) titled ``Medicare 
Program; Prior Authorization Process for Certain Durable Medical 
Equipment, Prosthetics, Orthotics, and Supplies,'' we implemented 
section 1834(a)(15) of the Act by establishing an initial Master List 
(called the Master List of Items Frequently Subject to Unnecessary 
Utilization) of certain DMEPOS that the Secretary determined, on the 
basis of prior payment experience, are frequently subject to 
unnecessary utilization and by establishing a prior authorization 
process for these items. In the same final rule, we also stated that we 
would inform the public of those DMEPOS items on the Required Prior 
Authorization List in the Federal Register with 60-day notice before 
implementation. The Required Prior Authorization List specified in 
Sec.  [thinsp]414.234(c)(1) is selected from the Master List of Items 
Frequently Subject to Unnecessary Utilization (as described in Sec.  
[thinsp]414.234(b)(1)), and items on the Required Prior Authorization 
List require prior authorization as a condition of payment.
    In addition to the prior authorization process for certain DMEPOS 
items that we established under section 1834(a)(15) of the Act, on 
September 1, 2012, we implemented the Medicare Prior Authorization for 
Power Mobility Devices (PMDs) Demonstration that would operate for a 
period of 3 years (September 1, 2012 through August 31, 2015). This 
demonstration was established under section 402(a)(1)(J) of the Social 
Security Amendments of 1967 (42 U.S.C. 1395b-1(a)(1)(J)), which 
authorizes the Secretary to conduct demonstrations designed to develop 
or demonstrate improved methods for the investigation and prosecution 
of fraud in the provision of care or services provided under the 
Medicare program. The demonstration was initially implemented in 
California, Florida, Illinois, Michigan, New York, North Carolina, and 
Texas. These states were selected for the demonstration based upon 
their history of having high levels of improper payments and incidents 
of fraud related to PMDs. On October 1, 2014, we expanded the 
demonstration to 12 additional states (Pennsylvania, Ohio, Louisiana, 
Missouri, Washington, New Jersey, Maryland, Indiana, Kentucky, Georgia, 
Tennessee, and Arizona) that had a history of high expenditures and 
improper payments for PMDs based on 2012 billing data. On July 15, 
2015, we announced we were extending the demonstration for 3 years, 
through August 31, 2018. The demonstration ended as scheduled on August 
31, 2018.
    In a June 5, 2018 Federal Register document, we announced that, 
effective September 1, 2018, we would add 31 HCPCS codes that were a 
part of the PMD demonstration to the Required Prior Authorization List 
(83 FR 25947).

II. Provisions of the Document

    The purpose of this document is to inform the public that we are 
updating the Required Prior Authorization List of DMEPOS items that 
require prior authorization as a condition of payment to include seven 
additional power mobility devices and five pressure reducing support 
surfaces. These 12 items are on the Master List of Items Frequently 
Subject to Unnecessary Utilization. To assist stakeholders in preparing 
for implementation of the prior authorization program, we are providing 
90 days' notice.
    The following seven HCPCS codes for PMDs are being added to the 
Required Prior Authorization List:

------------------------------------------------------------------------
          HCPCS code                          Description
------------------------------------------------------------------------
K0857........................  Power wheelchair, group 3 standard,
                                single power option, captains chair,
                                patient weight capacity up to and
                                including 300 pounds.
K0858........................  Power wheelchair, group 3 heavy duty,
                                single power option, sling/solid set/
                                back, patient weight 301 to 450 pounds.
K0859........................  Power wheelchair, group 3 heavy duty,
                                single power option, captains chair,
                                patient weight capacity 301 to 450
                                pounds.
K0860........................  Power wheelchair, group 3 heavy duty,
                                single power option, sling/solid seat/
                                back, patient weight capacity 451 to 600
                                pounds.
K0862........................  Power wheelchair, group 3 heavy duty,
                                multiple power option, sling/solid seat/
                                back, patient weight capacity 301 to 450
                                pounds.
K0863........................  Power wheelchair, group 3 heavy duty,
                                multiple power option, sling/solid seat/
                                back, patient weight capacity 451 to 600
                                pounds.
K0864........................  Power wheelchair, group 3 extra heavy
                                duty, multiple power option, sling/solid
                                seat/back, patient weight capacity 601
                                pounds or more.
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[[Page 16617]]

    In phase one of implementation, which begins as specified in the 
DATES section of this document, we will implement a prior authorization 
program for these seven HCPCS codes for PMDs nationwide. The nationwide 
prior authorization program for these seven HCPCS codes will continue 
during phase 2. We believe prior authorization of these seven 
additional HCPCS codes for PMDs will help further our program integrity 
goals of reducing fraud, waste, and abuse, while protecting access to 
care.
    The following five HCPCS codes for Support Surfaces are also being 
added to the Required Prior Authorization List:

------------------------------------------------------------------------
               HCPCS code                          Description
------------------------------------------------------------------------
E0193..................................  Powered Air Flotation Bed (Low
                                          Air Loss Therapy).
E0277..................................  Powered pressure-reducing air
                                          mattress.
E0371..................................  Nonpowered advance pressure
                                          reducing overlay for mattress
                                          length and width.
E0372..................................  Powered air overlay for
                                          mattress, standard mattress
                                          length and width.
E0373..................................  Nonpowered advanced pressure
                                          reducing mattress.
------------------------------------------------------------------------

    The CMS' Comprehensive Error Rate Testing (CERT) program continues 
to estimate high rates of improper payments for support surface codes. 
Since 2015, the estimated improper payment rate for these codes is over 
59 percent, with an estimated improper payment rate of 75.2 percent, or 
over $18 million in projected improper payments for fiscal year 2018.
    We will implement a prior authorization program for these five 
HCPCS codes for Support Surfaces in two phases. This phased-in approach 
will allow us to identity and resolve any unforeseen issues by using a 
smaller claim volume in phase one before nationwide implementation 
occurs in phase two. In phase one of implementation, which begins as 
specified in the DATES section of this document, we will limit the 
prior authorization requirement to one state in each of the four DME 
Medicare Administrative Contractors (MAC) geographic jurisdictions, as 
follows: California, Indiana, New Jersey, and North Carolina. In phase 
two, which begins as specified in the DATES section of this document, 
we will expand the program to the remaining states.
    We believe prior authorization of these five HCPCS codes for 
Support Surfaces will help further our program integrity goals of 
reducing fraud, waste, and abuse, while protecting access to care.
    These additional 12 HCPCS codes will be subject to the requirements 
of the prior authorization program for certain DMEPOS items as outlined 
in Sec.  414.234. All 33 HCPCS codes currently on the Required Prior 
Authorization List (81 FR 93636 and 83 FR 25947) will continue to be 
subject to the requirements of prior authorization as well.
    Prior to furnishing the item to the beneficiary and prior to 
submitting the claim for processing, a requester must submit a prior 
authorization request that includes evidence that the item complies 
with all applicable Medicare coverage, coding, and payment rules. 
Consistent with Sec.  414.234(d), such evidence must include the order, 
relevant information from the beneficiary's medical record, and 
relevant supplier-produced documentation. After receipt of all 
applicable required Medicare documentation, CMS or one of its review 
contractors will conduct a medical review and communicate a decision 
that provisionally affirms or non-affirms the request.
    We will issue specific prior authorization guidance in 
subregulatory communications, including final timelines, which are 
customized for the DMEPOS items subject to prior authorization, for 
communicating a provisionally affirmed or non-affirmed decision to the 
requester. In the December 30, 2015 final rule (80 FR 81694), to allow 
us to safeguard beneficiary access to care, we stated that this 
approach to final timelines provides the flexibility to develop a 
process that involves fewer days, as may be appropriate. If at any time 
we become aware that the prior authorization process is creating 
barriers to care, we can suspend the program.
    The updated Required Prior Authorization list is available in the 
download section of the following CMS website: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/DMEPOS/Prior-Authorization-Process-for-Certain-Durable-Medical-Equipment-Prosthetic-Orthotics-Supplies-Items.html. We 
will post additional educational resources to the website.

III. Collection of Information Requirements

    This document announces the addition of DMEPOS items on the 
Required Prior Authorization List and does not impose any new 
information collection burden under the Paperwork Reduction Act of 
1995. However, there is an information collection burden associated 
with this program that is currently approved under OMB control number 
0938-1293 which expires on March 31, 2022.

    Dated: March 19, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2019-08031 Filed 4-18-19; 4:15 pm]
 BILLING CODE 4120-01-P